Abstract

METHOD DEVELOPMENT AND VALIDATION FOR SIMULTANEOUS ESTIMATION OF DUTASTERIDE AND TAMSULOSIN HYDROCHLORIDE BY RP-HPLC METHOD IN PHARMACEUTICAL DOSAGE FORM

Dr.Ch. Saibabu*, B. Prathibha, Dr. M. Bhaskar

Abstract

The present work was undertaken with the aim to develop and validate a rapid and consistent RP-HPLC method in which the peaks will be appear with short period of time as per ICH Guidelines. The Purpose of this work to develop an accurate, simple, sensitive and precise RP-HPLC method was developed for the determination of dutasteride and tamsulosin hydrochloride in tablet dosage form. The RP-HPLC separation was achieved on BDS Hypersil C18 column (250 mm, id 4.6 mm, 5 μm) using mobile phase CH3COONH4: Methanol (55:45)v/v) at a flow rate of 0.8 ml/min at an 30⁰C temperature. Quantification was achieved with photodiode array detection at 254 nm over the concentration range 80μg/ml. The proposed method was validated for its linearity. Statistically, accuracy ,precision and robustness. This method can be employed for routine quality control analysis of Dutasteride and Tamsulosin Hydrochloride in tablet dosage form, and also applied successfully for the determination of dutasteride and tamsulosin Hydrochloride in combination of pharmaceutical dosage form. The method was simple, precise, accurate and sensitive and applicable for the simultaneous determination of Dutasteride and Tamsulosin hydrochloride in bulk drug and in combined dosage forms.

Keywords: Tamsulosin Hcl, dutasteride, RP-HPLC.